Z-1138-2022Class I

In-Line ventilator adaptor

Name: Z-1138-2022 In-Line ventilator adaptor
Creator: Baxter Healthcare Corporation
Published: 2022-04-26
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-04-26 / Terminated / root cause: design

FDA source

Baxter Healthcare Corporation began a recall of In-Line ventilator adaptor on 2022-04-26. FDA classified it as Class I and gives the reason as "There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1138-2022
Classification: Class I
Status: Terminated
Initiated: 2022-04-26
Posted: 2022-05-30
Terminated: 2024-08-20
Recalling firm: Baxter Healthcare Corporation
Product: In-Line ventilator adaptor
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
Reason for recall: There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
Root cause tag: design
FDA root cause: Device Design
Action: The recall notification was sent to consignees on 04/26/2022 via FedEx. The customer was instructed to sign acknowledgement form to confirm receipt and return to Hillrom using pre-paid envelope.
Quantity in commerce: 259 units
Distribution: US Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL, NC, OH, MI, MS, MO, MN, AL, TN, SD, OK, NV, NJ, IN, CO, GA, WA, PA, IA, NE, NM, SC, ND, KS, WV, OR.
Product codes and lots: M08473 OPTIMUS OLE AC PAT.CIRCUIT KIT; UDI-DI: 00887761981492. Manufacturing dates February 28, 2020 to present.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1138-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1138-2022	Class I	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-30
Z-1139-2022	Class I	Terminated	Voluntary: Firm initiated	2022-06-08	2022-05-30

Product code NHJ

K200988Class IIMaximus SystemHill-Rom Services Pte, Ltd. / cleared 2020-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)